Smith & Nephew, Inc. recalls smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis.
- Recall date
- May 2, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1921-2018
- FDA classification
- Class II
- Brand / firm
- Smith & Nephew, Inc.
- Sold / distributed
- US nationwide distribution.
Why it was recalled
Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length. The device taper length was incorrectly manufactured as 0.393mm opposed to 0.442 mm.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis.
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